But minorities have made gains in representation, review finds

Older people and women were just as underrepresented in heart failure (HF) clinical trials in 2016 as they were in 2001, according to a systematic review.

Patients in heart failure with preserved ejection fraction (HFpEF) trials averaged 71 years old versus 73 in U.S. epidemiological studies. Among those with reduced ejection fraction (HFrEF), the averages were 65 versus 69 years.

The gap was particularly notable in acute HF, at 66 versus 73 years as the mean age, Javed Butler, MD, MPH, MBA, of University of Mississippi in Jackson, and colleagues reported online in JAMA Cardiology.

The proportion of women across the study period from 2001-2016 was:

In HFpEF, 56% in trials versus 62% in epidemiological studies

In HFrEF, 24% in trials versus 29% in studies

In acute HF, 32% in trials versus 50% in studies

Their meta-analysis of 118 trials (n=215,508) showed that 55% of studies reported the distribution of racial and ethnic groups. From these, Butler's group saw an upward trend in non-white participants (13% in 2001-2004 to 30% in 2013-2016, P=0.01).

"We demonstrate that discrepancies in traditionally underrepresented patient groups between trials and ejection fraction-specific registry/community studies data sources persist but appear more modest than previously reported," they said. "Targeted efforts to enroll representative proportions of these cohorts are important now more than ever."

Behind the increase in non-white race representation, the investigators suggested, is the recent and rapid globalization in HF clinical trials coupled with the increased selection of non-U.S. sites.

Additionally, NIH- and National Heart, Lung, and Blood Institute (NHLBI)-funded trials tended to have more non-white participants (31% versus 20% for other funding mechanisms, P=0.02). Although the number of these trials went up over the years, it was only the industry-sponsored studies that ramped up recruitment of racial minorities (from 11% in 2001-2004 to 31% in 2013-2016).

Improvement in the racial diversity of HF trials aside, there was no significant change in either the age or proportion of women over time.

However, NIH/NHLBI-funded trials did better on the proportion of women enrolled than those with other funding sources (36% versus 27%, P=0.004), and those government-sponsored studies continued to attract more women over the study period.

"Collaboration between investigators, funding agents, and community members are necessary to ensure broad access to trials and sufficient applicability of their results," concluded Butler and colleagues.

"First, future studies should be required to provide adequate description of age, sex, and race/ethnicity. Reporting of race/ethnicity distribution should be complete and in accordance with the 2012 U.S. FDA position statement," they suggested.

"Second, renewed efforts to improve representative patient participation, with incentives to accomplish this goal, are needed for North American sites in global HF clinical trials," the researchers continued, adding that "improved site-based enrollment of underrepresented minorities may require concerted, multilevel interventions."

It is possible that the demographic estimates derived from U.S. HF epidemiological studies are not accurate, since these studies are subject to enrollment challenges and are restricted to specific communities, Butler's group cautioned.

Another limitation was that the number of non-white participants may have been overestimated due to the potential reporting bias of trials that chose to publish breakdowns of patient race and ethnicity.

Butler has received research support from the NIH and European Union and has been a consultant for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CVRx, Janssen, Luitpold Pharmaceuticals, Medtronic, Merck, Novartis, Relypsa, Vifor Pharma, and ZS Pharma.

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